A Clinical Assessment of the Safety and Efficacy of VELVERT® Dressing in the Management of Necrotizing Fasciitis.

BACKGROUND

Necrotizing fasciitis (NF), a severe form of Necrotizing Soft Tissue Infection (NSTI), is a rapidly progressing, life-threatening condition characterized by extensive tissue destruction. Standard management involves early surgical debridement and systemic antibiotics; however, adjunctive wound care plays a crucial role in recovery. VELVERT®, a U.S.-patented dressing enriched with natural plant-based antimicrobials, has shown efficacy in chronic ulcers but has not yet been evaluated in NSTI.

OBJECTIVE

To assess the safety and efficacy of Velvert antimicrobial dressing as an adjunct to standard care in patients with NSTI.

METHODS

A single-center, open-label, non-randomized clinical study was conducted at M.L.B. Medical College, Jhansi, enrolling 20 patients (18-70 years) with clinically diagnosed NSTI. After debridement, Velvert dressings were applied every fourth day for up to 60 days. Primary endpoints included complete wound closure and rate of healing. Secondary assessments were ≥50% wound area reduction, pain relief, dressing frequency, microbial load, surgeon satisfaction, and adverse events. Both Intent-to-Treat (n=20) and Per-Protocol (n=18) analyses were performed. The study was registered with CTRI (CTRI/2024/02/063282).

RESULTS

Complete wound closure occurred in 61.11% (11/18) of Per-Protocol patients, with an additional 16.67% achieving ≥50% reduction. Mean wound size reduction was 20.73 cm2 (p=0.004). By Day 60, 60% reported no pain, and 77.78% showed ≥50% healing. Dressing usage ranged from 2-15 applications. No serious adverse events were observed, and surgeons reported high satisfaction. Microbial analysis indicated reduced bacterial load.

CONCLUSION

Velvert demonstrated safety and efficacy as an adjunct therapy in NSTI, enhancing wound healing, reducing pain, and offering a promising plant-based alternative to conventional dressings.